The primary objective of the study is to determine the maximally tolerated dose and recommended Phase 2 dose of CBL0137 when administered intravenously (IV) to patients with metastatic or unresectable advanced solid malignancies or refractory lymphomas.

All doses are on Days 1, 8 and 15 of every 28 day cycle. Number of Cycles: 2 or until progression or unacceptable toxicity develops

Detailed Description:

Patients must have documented recurrent or refractory solid tumors, or refractory lymphomas; patients enrolled in the dose-expansion part of the trial must have least one lesion that may qualify as a target lesion based on the RECIST 1.1 criteria. Following the provision of signed informed consent, patients will be screened for entry into the study. Screening numbers will be assigned by the site. Patients who do not meet entry criteria will not have their screening data entered into the database.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients must have histological or cytological evidence of a solid neoplasm or lymphoma

Patients enrolled in the expansion cohort must have at least one measureable lesion as defined by the RECIST 1.1 criteria

Patients must:

have metastatic or unresectable advanced solid tumors or refractory lymphomas that have recurred or progressed following standard therapy or

no longer be candidates for standard therapy or

have tumors for which there is no standard therapy

Patients must be ambulatory and have an ECOG Performance Score of 0 or 1;

Patients or their legal representative must be able to provide written informed consent;

Serum AST/ALT < 3X the upper limit of normal (ULN) for the reference lab (< 5X the ULN for patients with known hepatic metastases)

Serum bilirubin < 1.5 x the ULN for the reference lab;

Exclusion Criteria:

Patients with active infection or with a fever > 38.50 C within 3 days of the first scheduled day of dosing;

Patients with primary CNS tumors or symptomatic CNS metastases who have not undergone surgery and/or radiotherapy and/or who are not neurologically stable;

Patients with known hypersensitivity to any of the components of CBL0137;

Patients who are receiving concurrent investigational therapy; for patients who have recently received investigational therapy, 5 half-lives must have elapsed between the last dose of investigational drug and the first dose of CBL0137. If the half-live is unknown, 4 weeks must have elapsed between the last dose of investigational drug and the first dose of CBL0137 (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication in the United States);

Males with mean QTcF values of > 450 msec and females with QTcF values of > 470 msec following 3 ECGs conducted 5 minutes apart from each other; patients who are known to have congenital prolonged QT syndromes; or patients who are on medications known to cause prolonged QT intervals on ECG;

Please speak with the PI for the complete Inclusion/Exclusion listing.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01905228